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This article was originally published in Pharmaceutical Approvals Monthly
FDA issues "not approvable" letter for the combination of uracil and tegafur March 23. The NDA, which was seeking approval of UFT for use with leucovorin in the treatment of advanced colorectal cancer, originally was submitted in February 1999 and was resubmitted April 20, 2000. BMS says it will consider "all available options to obtain approval of UFT in the U.S.
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